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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Nov. 15, 2018

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Newer Nonstick Coating May Pose Health Threat: EPA A chemical compound used to make newer nonstick coatings could be dangerous, according to draft findings from the U.S. Environmental Protection Agency. It said that animal studies show the so-called GenX nonstick compound could affect the kidneys, blood, immune... Read more

The Jobs That Carry the Highest Suicide Risk

Posted today in Medical

THURSDAY, Nov. 15, 2018 -- The rate of suicide among U.S. workers has jumped 34 percent since 2000, and certain occupations seem to be riskier than others, government health researchers report. Those most at risk: men with construction and extraction jobs, and women in arts, design, entertainment, sports and media, according to the U.S. Centers for Disease Control and Prevention. "Increasing suicide rates in the... Read more

AHA: Caring for Loved One With Heart Failure Even Tougher for Rural Americans

Posted today in Medical

THURSDAY, Nov. 15, 2018 (American Heart Association) -- Living in a rural area increases the difficulty of caring for someone with heart failure, according to new research. An estimated 6.5 million U.S. adults ages 20 and older have heart failure, a serious condition that develops when the heart can't pump enough blood and oxygen to support other organs in the body. People with heart failure often experience... Read more

FDA Moves to Restrict Flavored E-Cig Sales, Ban Menthol Cigarettes

Posted today in Medical

THURSDAY, Nov. 15, 2018 -- The U.S. Food and Drug Administration said Thursday it will take steps to limit or ban access to flavored e-cigarettes, menthol cigarettes and flavored cigars. The move against flavored e-cigarettes stops short of the full ban that had been expected from the agency. Instead, sales of these products -- thought to be especially alluring to teens -- will only be allowed in stores within... Read more

Climate Change Could Change the Ragweed Sneezin' Season

Posted today in Medical

THURSDAY, Nov. 15, 2018 -- If you live in Maine and you've never experienced hay fever, new research predicts that climate change has an unwelcome surprise in store for you. Warmer temperatures in the northern United States will allow ragweed -- the plant that triggers hay fever -- to flourish in areas it's never been before. About 35 years from now, the study predicts, ragweed will be found in New Hampshire,... Read more

CDC: Many Americans May Have Prediabetes and Not Know It

Posted today in News for Health Professionals

THURSDAY, Nov. 15, 2018 -- More than one-third of Americans have prediabetes, but 90 percent of them do not know they have it, medical experts say. Nov. 14 was World Diabetes Day, and the American Medical Association and U.S. Centers for Disease Control and Prevention launched a campaign to raise awareness about prediabetes and encourage people to find out if they have the condition. "Prediabetes can often be... Read more

Option Found for Retreatment of Chronic Hep C Infection

Posted today in News for Health Professionals

THURSDAY, Nov. 15, 2018 -- Combined treatment with glecaprevir and pibrentasvir (G/P) is highly effective in treating chronic hepatitis C virus (HCV) genotype-1 infections that failed to respond to direct-acting antiviral therapy, according to a study presented at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases, held from Nov. 9 to 13 in San Francisco. Mark S.... Read more

Many Patients Do Not Engage Health Care Provider During MS Relapse

Posted today in News for Health Professionals

THURSDAY, Nov. 15, 2018 -- The rate and frequency of relapse vary for patients with multiple sclerosis (MS), and many report not visiting a health care provider during relapse, according to a study published in the November issue of Multiple Sclerosis and Related Disorders. Tara A. Nazareth, from Mallinckrodt Pharmaceuticals in Bedminster, New Jersey, and colleagues used data from the Multiple Sclerosis in America... Read more

Mental Health Conditions, Suicide Up After Major Trauma

Posted today in News for Health Professionals

THURSDAY, Nov. 15, 2018 -- Survivors of major trauma have an elevated risk for mental health conditions or death by suicide in the five years after injury, according to a study published in the Nov. 12 issue of CMAJ, the journal of the Canadian Medical Association. Christopher C.D. Evans, M.D., from Queen's University in Kingston, Canada, and colleagues completed a population-based self-controlled longitudinal study... Read more

Breast Cancer Recurrence Rate Not Up With Autologous Fat Transfer

Posted today in News for Health Professionals

THURSDAY, Nov. 15, 2018 -- For patients with breast cancer, reconstruction with autologous fat transfer (AFT) seems not to increase the rate of locoregional recurrence versus conventional breast reconstruction, according to a study published online Oct. 10 in JAMA Surgery. Todor Krastev, M.D., Ph.D., from the Maastricht University Medical Center in the Netherlands, and colleagues matched 287 patients with 300... Read more

Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine

Posted yesterday in New Drug Applications

INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct... Read more

FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)

Posted 6 days ago in New Drug Approvals

DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with... Read more

FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma

Posted 8 days ago in New Drug Approvals

RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene Mist is... Read more

Bausch Health Announces U.S. Launch of Bryhali (halobetasol propionate) Lotion, 0.01%, for Plaque Psoriasis In Adults

Posted 8 days ago in New Drug Approvals

LAVAL, Quebec, Nov. 7, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start distribution of Bryhali (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month. The company received final approval from the... Read more

FDA Approves Empliciti (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma

Posted 9 days ago in New Drug Approvals

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1 In... Read more

FDA Approves Udenyca (pegfilgrastim-cbqv), a Biosimilar to Neulasta

Posted 12 days ago in New Drug Approvals

REDWOOD CITY, Calif., Nov. 02, 2018 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ: CHRS), today announced that the U.S. Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca is Coherus’ first drug to receive FDA or EC a... Read more

Trevena Receives Complete Response Letter for Oliceridine from FDA

Posted 13 days ago in New Drug Applications

November 2, 2018 -- Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine,” said Carrie L. Bourdow,... Read more

Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression

Posted 13 days ago in New Drug Applications

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes,... Read more

Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

Posted 2 weeks ago in New Drug Applications

DUBLIN, Nov. 1, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), met to review the company's New Drug Application (NDA) for ALKS 5461. The committee jointly voted that the benefit-risk profile was not adequate to support... Read more

Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management

Posted 2 weeks ago in New Drug Applications

SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational,... Read more

Attenua Announces First Patient Treated in Phase 2 Clinical Trial in Chronic Cough with Bradanicline

Posted today in Clinical Trials

San Mateo, Calif, Nov 14, 2018 – Attenua, Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to treat cough, today announced that the first patient has been treated in a Phase 2 clinical trial in chronic cough with bradanicline (formerly known as ATA-101), its lead compound. “Within just six months of our initial Series A funding, Attenua has successfully filed an... Read more

Entasis Therapeutics Announces Zoliflodacin Phase 2 Results Published in The New England Journal of Medicine

Posted 7 days ago in Clinical Trials

WALTHAM, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced that The New England journal of Medicine (NEJM) published results from a Phase 2 clinical trial evaluating the safety and efficacy of zoliflodacin in patients with uncomplicated gonorrhea. Zoliflodacin... Read more

Janssen Reports Positive Topline Results for FLAIR Phase 3 Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1

Posted 2 weeks ago in Clinical Trials

CORK, IRELAND, October 31, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase 3 FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. The study, conducted by ViiV Healthcare, showed long-acting rilpivirine and cabotegravir, injected once a month, had... Read more

Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD

Posted 2 weeks ago in Clinical Trials

Basel, 27 October, 2018 - Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks)[1],[2]. Secondary endpoints at year two (96 weeks) reaffirmed superiority of... Read more

New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)

Posted 2 weeks ago in Clinical Trials

South San Francisco, CA -- October 27, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD), a leading cause of blindness in people aged 60 and over in the United States.3 At 52 weeks, faricimab patients... Read more